Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT03152435
Eligibility Criteria:
Inclusion Criteria:
* 1\. Patients must be 18 years to 70 years;
* 2\. Clinical diagnosis of EGFR positive for patients with metastatic colorectal cancer;
* 3\. Patients must have a KPS of \>80, expected survival \> 3 months;
* 4\. Patients must have at least one measurable lesions;
* 5\. Recently did not use glucocorticoid;
* 6\. Patients must have evidence of adequate hepatic and renal function as evidenced by the following laboratory parameters: WBC ≥ 4.0×109/L, Hb ≥90 g/L, PLT ≥100×109/L）; AST ≤2.5ULN，ALT ≤ 2.5ULN; Cr≤ 3ULN; TBIL≤ 3ULN，
* 7\. Patients must have a good heart function (LVEF\>50%) ;
* 8\. Patients must be willing to practice birth control during and for three months following treatment.NOTE:female participants of reproductive potential must have a negative serum pregnancy test, and willing to practice birth control during and for three months following treatment；
* 9\. Patients must be willing to sign an informed consent.
Exclusion Criteria:
* 1\. Patients with other cancer history;
* 2\. Patients allergic to cetuximab;
* 3\. Patients with severe bronchitis, bronchial asthma, or severs pneumonia;
* 4\. Patients with uncontrolled active infections (bacteria, viruses or fungi infection) ;
* 5\. Patients with acute and chronic GVHD (graft versus host disease)
* 6\. Patients with severe autoimmune diseases;
* 7\. Previously treatment with T cell inhibitors (cyclophosphamide, FK506);
* 8\. Patients with active hepatitis B or hepatitis C infection, HIV infection, syphilis serology reaction positive;
* 9\. Patients who are participating or participated any other clinical research in the past 1 months;
* 10\. Pregnant and/or lactating women will be excluded;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03152435
Study Brief:
Protocol Section:
NCT03152435